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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Change to section 4.6 - Pregnancy and lactation

Change to section 4.8 - Undesirable effects

Change to section 4.9 - Overdose

Date of revision of text on the SPC: 31-Mar-2014

Legal Category: Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company

﻿Section 4.2 reformatted to include more comprehensive directions for use. Advice to cover with a dressing, and warning about flammability addedSection 4.4 reformatted and warning to store out of reach and sight of children addedSection 4.5 Section previously stated none knownSection 4.6 Now not recommended during pregnancy and lactationSection 4.8 reformatted to include frequencySection 4.9 treatment section added

Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Change to section 4.6 - Pregnancy and lactation

Change to section 4.8 - Undesirable effects

Change to section 4.9 - Overdose

Change to section 5.1 - Pharmacodynamic properties

Change to section 5.3 - Preclinical safety data

Change to section 6.5 - Nature and contents of container

Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 31-Mar-2010

Legal Category: Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company

﻿

1.NAME OF THE MEDICINAL PRODUCT

DUOFILM Cutaneous Solution

Salicylic Acid 16.7% w/w

Lactic Acid 16.7% w/w

4.2Posology and method of administration

DUOFILM should be applied to warts once daily.

Children under 12 years should only use the product under supervision.

Treatment of infants under the age of 2 years is not recommended.

The patient should be instructed as follows. Soak the warts in warm water for 5 minutes. Rub surface of warts carefully with pumice stone or emery board. Apply, taking care to avoid normal skin. Allow to dry thoroughly. Continue treatment until the wart is completely cleared. If warts persist beyond 12 weeks of treatment, the patient should be advised to consult their doctor.

4.3 Contraindications

Hypersensitivity to the active substances or to any of the excipients.

Do not use on open skin wounds, moles, birthmarks, genital warts, warts on the face, or warts with hair growing from them, red edges, or unusual colour.

Avoid applying to normal skin.

DUOFILM should not be used on the face or anogenital regions.

Special warnings and precautions for use

This medicinal product is for external use only.

Avoid getting the product in the eyes, nose, or mouth, or on the genital and anal areas. If contact with the eyes occurs, flush with water for 15 minutes. Avoid inhaling vapour.

Ensure this product is stored out of the reach of children to avoid accidental ingestion.

Consider alternative treatments if warts cover a large area of the body (more than 5 cm2).

Patients with diabetes and patients suffering from peripheral blood circulation conditions should only use the product under medical supervision.

Care should be taken to apply the product only to the wart and not to the normal skin surrounding the wart. Do not apply to reddened, inflamed or damaged skin.

Although a theoretical risk with topical salicylates, oral salicylates have been associated with Reye’s syndrome. Therefore, use is not advised in children or teenagers during or immediately after chickenpox, influenza, or other viral infections.

1.Care should be taken to ensure that the product is not applied to surrounding skin, as this may result in burning of the normal skin.

2.The product should be kept away from the eyes and mucous membranes.Thorough flushing with water should be carried out to remove any material accidentally in contact with these tissues.

4.5Interaction with other medicinalproducts and other forms of interactions

Embryo-toxicity effects in humans have not been studied but studies in animals demonstrated embryo-toxicity at high doses.

The systemic absorption from using this topical product is limited.

Caution should be exercised when prescribing to pregnant women.

Prolonged use of Duofilm during pregnancy and lactation should be avoided. The area of treatment should not exceed 5 cm².

If used during lactation, it should not be applied to the chest to avoid accidental ingestion by the infant.

There are no restrictions on the use of DUOFILM in pregnancy and lactation.

4.8Undesirable effects

Application of DUOFILM to normal skin may result in burning.

A localised irritant reaction will occur if applied to the normal skin surrounding the wart. The irritation will normally be controlled by temporarily discontinuing use and by applying the medication only to the wart site when treatment is resumed. Reported adverse drug reactions from postmarketing experience include burning sensation, pain, erythema, skin discolouration, pruritis, exfoliation, bleeding, inflammation, contact dermatitis and swelling.

4.9Overdose

Excessive use could cause irritation of the skin. If this occurs, use more sparingly or apply less frequently. In the event of accidental oral ingestion, especially in infants or children, monitor and provide appropriate supportive measures. Symptoms may include headache, nausea, vomiting, diarrhoea and hyperpnoea.Not applicable.